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The primary objective of this study is to prospectively assess in randomized fashion whether short term anti-seizure prophylaxis in traumatic brain injured patients decreases the incidence of seizures in the early post-injury period. A secondary objective is to evaluate whether there are differences in mortality, hospital length of stay, functional outcome at hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.) for patients who receive and do not receive anti-seizure prophylaxis.
The efficacy of anti-seizure prophylaxis in head injury patients remains controversial. Current recommendations for the use of anti-seizure prophylaxis are based upon a single institution study that has not been reproduced with other studies contradicting their conclusions. The proposed study will be a randomized prospective study at Loyola University Medical Center to assess the efficacy of anti-seizure prophylaxis in patients who have suffered traumatic brain injury (TBI). Patients with suspected TBI will undergo computed tomographic (CT) scan of the head. Following identification of TBI on CT scan, patients will be randomized to one of two study groups. Patients will be randomized to receive a seven-day course of anti-seizure prophylaxis with levetiracetam (UCB Pharma Inc.; Keppra) or randomized to a study group that will not receive anti-seizure prophylaxis. Patients will be consented prior to entry in the study. Patients will be followed for a total of seven days post injury for clinical signs of seizure activity. Additionally, patients will be assessed at one month post injury for clinical signs of seizure activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No seizure prophylaxis | No Intervention | Participants randomized to this arm will not receive anti-seizure prophylaxis | |
| Seizure Prophylaxis | Experimental | Participants randomized to this arm will receive the anti-seizure prophylaxis drug Levetiracetam for seven days post traumatic brain injury. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Participants assigned to the experimental arm will receive a seven day course of levetiracetam for post-traumatic brain injury |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seizures (count of seizures) | For all patients, the count of seizures will be recorded and compared between the two arms | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | For all patients, days from head injury to death or last follow-up will be recorded and compared between the two arms. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard P Gonzalez, MD | Contact | 708-327-2072 | richard.gonzalez@lumc.edu | |
| Michael Anstadt, MD | Contact | 708-327.2072 | manstadt@lumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard Gonzalez, MD | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Recruiting | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24554454 | Background | Pitkanen A, Immonen R. Epilepsy related to traumatic brain injury. Neurotherapeutics. 2014 Apr;11(2):286-96. doi: 10.1007/s13311-014-0260-7. | |
| 24249751 | Background | Torbic H, Forni AA, Anger KE, Degrado JR, Greenwood BC. Antiepileptics for seizure prophylaxis after traumatic brain injury. Am J Health Syst Pharm. 2013 Dec 1;70(23):2064, 2067. doi: 10.2146/ajhp130439. No abstract available. |
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There is no plan to share individual participant data.
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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The intervention study model is a randomized block design using a 1:1 allocation scheme
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|
| 25712562 | Background | Cranley MR, Craner M, McGilloway E. Antiepileptic prophylaxis following severe traumatic brain injury within a military cohort. J R Army Med Corps. 2016 Apr;162(2):109-14. doi: 10.1136/jramc-2014-000392. Epub 2015 Feb 24. |
| 2115976 | Background | Temkin NR, Dikmen SS, Wilensky AJ, Keihm J, Chabal S, Winn HR. A randomized, double-blind study of phenytoin for the prevention of post-traumatic seizures. N Engl J Med. 1990 Aug 23;323(8):497-502. doi: 10.1056/NEJM199008233230801. |
| 6409521 | Background | Young B, Rapp RP, Norton JA, Haack D, Walsh JW. Failure of prophylactically administered phenytoin to prevent post-traumatic seizures in children. Childs Brain. 1983;10(3):185-92. doi: 10.1159/000120113. |
| 24368357 | Background | Bhullar IS, Johnson D, Paul JP, Kerwin AJ, Tepas JJ 3rd, Frykberg ER. More harm than good: antiseizure prophylaxis after traumatic brain injury does not decrease seizure rates but may inhibit functional recovery. J Trauma Acute Care Surg. 2014 Jan;76(1):54-60; discussion 60-1. doi: 10.1097/TA.0b013e3182aafd15. |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |